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Oxidative Stress and Hemodialysis Access Failure

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status

Completed

Conditions

Hemodialysis
End Stage Renal Disease

Treatments

Drug: Alpha tocopherol

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00410449
NIEHS ES11461
11461-CP-001

Details and patient eligibility

About

Complications of hemodialysis access are the most frequent single reason for hospitalization among patients with End Stage Renal Disease (ESRD). Uremia, and particularly uremia in patients with diabetes, is a state of increased oxidative stress. The central hypothesis to be tested by this project is that oxidative stress is a major (and modifiable) trigger for vascular access complications. We hope to slow or reduce rates of stenosis, thrombosis and access complications by giving Vitamin E supplementation to patients being treated by hemodialysis.

Full description

Patients continued their usual treatment on hemodialysis three times per week. This was a double-blinded placebo controlled trial. Patients took either Vitamin E 400 IU bid or placebo. An initial evaluation of access patency was performed and baseline blood drawn before starting Vitamin E. Every 3 months there was a followup evaluation with blood drawn for oxidative stress markers, and with a test of vascular access patency. The study was closed to new participants, vitamin E or placebo stopped, and data analysis performed in 2003.

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula)

Exclusion criteria

Temporary catheter dialysis access, inability to be compliant with study medication

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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